Preparing For (and Protecting Your Company During) an FDA Inspection

Our Lawyers and Former FDA Agents Help Companies in All Industries Survive FDA Inspections

**Attorney Nick Oberheiden**
FDA Inspection Preparation Team Lead

**Attorney Lynette Byrd**
FDA Inspection Preparation Team Lead
Former DOJ Attorney

Attorney John Sellers — **John W. Sellers**
FDA Inspection Preparation Team Lead
Former Senior DOJ Trial Attorney

The U.S. Food and Drug Administration (FDA) conducts inspections under a variety of circumstances. Along with inspecting applicants’ facilities during the pre-market approval (PMA) process, the FDA also conducts inspections during post-market surveillance to assess compliance, and it conducts inspections in response to specific health and safety concerns as well and will take corrective and preventive actions where necessary. In all scenarios, FDA inspections can present substantial risks, as evidence of noncompliance with FDA regulations can have consequences ranging from PMA denial to a mandatory recall, with companies (and their owners and executives) potentially facing exposure to civil fines or criminal penalties in some cases.

We help companies successfully navigate FDA inspections and regulatory compliance in all scenarios. Our lawyers and consultants have extensive experience handling FDA inspections not only as advisors to companies in the private sector, but also within the FDA in many cases. With a team that includes a former Director of Compliance and former FDA Investigator, as well as a former Special Agent in the FDA’s Office of Criminal Investigations, we understand the FDA’s processes and procedures from the inside out. We rely on this understanding to help our clients thoroughly prepare for their FDA inspections and to advise and represent them throughout the FDA inspection process.

Types of FDA Inspections We Handle

Our lawyers and consultants assist companies with preparing for all types of FDA inspections. We work with companies in all FDA-regulated industries, including pharmaceuticals, vaccines, biologics, medical devices, veterinary products, food, cosmetics, tobacco, and radiation-emitting electronic devices. We regularly assist clients with the following:

Application-Based Inspections

The FDA conducts inspections as part of the PMA review process for pharmaceuticals, biologics, medical devices, and tobacco products. As the FDA explains, the focus of these inspections is on “ensur[ing] the facility is capable of manufacturing the product consistently and that submitted data are accurate and complete.” The FDA’s inspection is a critical step in the PMA process, and companies seeking the FDA’s approval need to ensure that they are fully prepared to pass.

Clinical and Non-Clinical Research Inspections

In parallel with conducting PMA inspections, the FDA also conducts inspections to “verify the reliability, integrity and compliance of clinical and non-clinical research being reviewed in support of pending applications.” The FDA has enhanced its focus on research data integrity in recent years, and companies that aren’t prepared to clearly demonstrate their data’s reliability can face steep consequences.

Surveillance Inspections

The FDA also conducts post-market surveillance inspections “to evaluate whether a manufacturer is complying with quality manufacturing practices.” Just like the FDA’s PMA inspections, these inspections present significant commercial and legal risks, and it is imperative that companies have the documentation needed to survive these inspections when they occur.

For-Cause Inspections

For-cause inspections focus on specific compliance-related concerns. The FDA conducts these inspections in two primary scenarios: (i) when it “has reason to believe that a facility has quality problems;” and, (ii) “to follow up on complaints or to evaluate corrections that have been made to address previous violations.” In many cases, when a company fails to satisfy the FDA’s concerns during a for-cause inspection, the company will face additional scrutiny in the form of a civil or criminal enforcement investigation.

What You Need to Know Before an FDA Inspection

Preparing for an FDA inspection is a multi-step process that requires a commitment to thorough and detail-oriented compliance. Developing a company’s operations and, if applicable, clinical trials around the FDA’s compliance expectations is a critical step, but companies must also do more in order to withstand the FDA’s scrutiny during an inspection. With this in mind, here is an overview of what company owners and executives need to know about preparing for an FDA inspection:

1. Thorough Preparation is Critical

During an FDA inspection, any compliance oversights can lead to a less-than-passing grade. Additionally, if there are any open questions regarding a company’s compliance, the FDA will typically err on the side of assuming that more effort is required. With this in mind, thorough preparation is critical, and this includes (but is not limited to):

Implementing a comprehensive internal FDA compliance program
Stress-testing the company’s compliance program in the FDA’s key areas of concern
Monitoring and auditing compliance in anticipation of the FDA’s investigation
Documenting the company’s ongoing compliance efforts
Instructing all relevant personnel on how and when to interact with the FDA

Again, these are just examples. When we represent manufacturers and other companies with respect to FDA compliance, we take a custom-tailored approach to helping our clients prepare to withstand FDA scrutiny. We help our clients address any specific compliance-related concerns, and we rely on our experience to help them get ready to deal with the FDA effectively.

2. FDA Inspections Can Be Invasive and Exhaustive

FDA inspections can be invasive. The FDA may request access to numerous types of records and request to speak with personnel throughout the organization. They can also be exhaustive. While some post-market inspections focus on specific compliance concerns, in most cases the FDA will be looking for any and all evidence of possible non-compliance.

3. Manufacturers and Other Companies Must Be Prepared to Affirmatively Demonstrate Compliance

Given the FDA’s exhaustive approach to conducting inspections and the risks of being found non-compliant, manufacturers and other companies must be prepared to affirmatively demonstrate full compliance during their FDA inspections. By helping our clients prepare and working with the FDA on their behalf, we help ensure that our clients do not face any unnecessary or unwarranted consequences.

4. The FDA Publishes Compliance Resources (and Expects Manufacturers and Other Companies to Use Them)

The FDA publishes a variety of compliance resources for manufacturers and other companies—and it expects companies to use them. These resources include the FDA’s Inspection Guides, which provide an in-depth overview of the FDA’s inspection policies and procedures not only in specific regulated industries, but also regarding specific types of regulated products. Reviewing the relevant Inspection Guides—as well as all other pertinent laws, regulations, and other sources of FDA authority—is a critical (and substantial) step toward preparing for an FDA inspection.

5. FDA Inspections Can Have Significant Adverse Consequences

As the FDA states, “[i]f a facility does not meet current good manufacturing practice standards (CGMPs) upon inspection, the FDA has an array of regulatory tools it can use to encourage a company to remediate their manufacturing processes and achieve compliance.” These regulatory tools include:

Warning letters
Withdrawal of approval or disqualification
Injunctions
Seizures
Import alerts
Mandatory recalls
Civil monetary penalties (CMP)

Dr. Nick Oberheiden

Founder

Attorney-at-Law

Lynette S. Byrd

Former DOJ Trial Attorney

Partner

Brian J. Kuester

Former U.S. Attorney

Hon. Kevin McCarthy

55th Speaker, U.S. House of Representatives (ret.)

Government Consultant

Mike Pompeo

Of Counsel

Former U.S. Secretary of State

John W. Sellers

Former Senior DOJ Trial Attorney

Linda Julin McNamara

Federal Appeals Attorney

Nicholas B. Johnson

Former Prosecutor

Roger Bach

Former Special Agent (DOJ)

Chris J. Quick

Former Special Agent (FBI & IRS-CI)

Michael S. Koslow

Former Supervisory Special Agent (DOD-OIG)

Ray Yuen

Former Supervisory Special Agent (FBI)

FAQs: Avoiding Adverse Outcomes From an FDA Inspection

When Do I Need to Be Prepared for an FDA Inspection?

Companies need to be prepared for FDA inspections at all times. While companies are most likely to face inspections during the PMA application process, the FDA can (and does) conduct inspections whenever it determines they are necessary. To avoid injunctions, CMP, and other adverse consequences, companies that are subject to the FDA’s oversight must consistently remain prepared to demonstrate compliance when necessary.

What Will the FDA Be Looking for During Its Inspection?

When conducting inspections, the FDA looks for any and all forms of non-compliance. This includes everything from non-compliance with the Current Good Manufacturing Practices (CGMP) to non-compliance with the laws and regulations that apply to specific regulated products and industries. To withstand the FDA’s scrutiny, companies must ensure that they are adequately addressing their compliance obligations in all aspects of their operations.

What Happens if the FDA Determines that a Company is Non-Compliant with the Current Good Manufacturing Practices (CGMP)?

If the FDA inspector determines that a company is non-compliant with the CGMP, it can take a number of corrective actions. It can deny the company’s PMA application, withdraw the company’s approval, issue a recall notice (in certain cases), and take various other steps to prevent the company from selling adulterated products to healthcare providers or consumers. The FDA can also follow up to determine whether companies have implemented effective corrective action plans, and it can pursue additional means of enforcement as warranted.

Can I Appeal the Outcome of an FDA Inspection?

It is possible to appeal the outcome of an FDA inspection. If you disagree with the FDA’s inspection report determinations and are not able to obtain a satisfactory resolution during the inspection process, our lawyers can assist with pursuing the next steps in the process.

Do I Need to Engage Outside Counsel for an FDA Inspection?

While not required, engaging outside counsel for an FDA inspection is strongly recommended. Even when a manufacturer’s or other company’s operations are fully FDA-compliant, demonstrating compliance isn’t necessarily a straightforward process. Experienced FDA compliance lawyers will be able to work with the FDA’s personnel effectively while advising you throughout the inspection process and assisting with any necessary next steps.

Speak with an FDA Compliance Lawyer or Consultant at Oberheiden P.C.

If you would like to know more about our FDA inspection practice, we invite you to get in touch. To speak with an FDA compliance lawyer or consultant at Oberheiden P.C., please call 888-680-1745 or request a complimentary consultation online today.